Healthy Controls
Conditions
Keywords
ME/CFS, Post-Covid, Biomarker
Brief summary
Using the data from the HelP study, the underlying processes of the diseases ME/CFS and PAIS are to be researched and elucidated. The comparison of affected patients with healthy controls is intended to identify disease-specific patterns that could be related to the development or progression of the disease. The aim is to find a suitable biomarker for diagnostics and to develop therapeutic approaches.
Detailed description
The underlying pathomechanisms of the diseases PAIS and ME/CFS are to be investigated and elucidated in more detail. The aim is to establish a cohort of healthy controls at our MRI Chronic Fatigue Center (MCFC). Within this cohort, the measurement instruments used so far in ME/CFS diagnostics will be validated. In addition, data material from this pool should be used for the statistical evaluations of various case-control studies of our center and our cooperation partners in order to find and develop a suitable biomarker for diagnostics and therapeutic approaches for PAIS and ME/CFS.
Interventions
DIAGNOSTIC_TESTDiagnostic Test
The following clinical data sources are used: * Personal interview (anamnesis) * Physical examination * Questionnaires * Functional assessment * Imaging techniques The following biological materials are used: • Max. 30 ml of blood
Sponsors
Charite University, Berlin, Germany
Max-Planck Institut
University Hospital Erlangen
Technical University of Munich
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure) * Age: 10 - 25 years * Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives
Exclusion criteria
* Acute illnesses (e.g. infections) or major injuries * Known chronic diseases (including psychological diagnoses) other than those mentioned above * Surgery or blood transfusion in the last 3 months * No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination * Pregnancy; Breastfeeding * Limited legal capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal data | Measurement is taken at a single time point right after enrollment | Name, date of birth, contact details |
| Clinical data | Measurement is taken at a single time point right after enrollment | Sex, vaccination status, level of education, occupation, smoking and alcohol behavior, other addictive behavior, competitive sports |
| Physical assessment | Measurement is taken at a single time point right after enrollment | weight and height will be combined to report BMI in kg/m\^2 |
| Heart rate | Measurement is taken at a single time point right after enrollment | beats per minute |
| Blood pressure | Measurement is taken at a single time point right after enrollment | in mmHg |
| Questionnaire data | Measurement is taken at a single time point right after enrollment | Following questionnaires are rated on a scale: MBSQ, Chalder Fatigue Scale, PedsQL Fatigue, Bell Score, DSQ-PEM, SF-36, PedsQL, EQ5D, PHQ4, Compass31 |
| YSR questionnaire | Measurement is taken at a single time point right after enrollment | Open questions and questions to be rated on a scale |
| Imaging | Measurement is taken at a single time point right after enrollment | OCT-A: Imaging of ocular fundus |
| Full blood count | Measurement is taken at a single time point right after enrollment | CRP, Ferritin, Creatinin, GPT and Immunglobuline |
| Deformability Cytometer | Measurement is taken at a single time point right after enrollment | Cell-deformation |
| Virology | Measurement is taken at a single time point right after enrollment | EBV, CMV, HSV1, HSV2 and Sars CoV2 antibodies |
| Immunology | Measurement is taken at a single time point right after enrollment | ANA, Cystatin C, dsDNA Ak |
| Endocrinology | Measurement is taken at a single time point right after enrollment | TPO antibodies |
| B-cell phenotyping | Measurement is taken at a single time point right after enrollment | Analysis of surface antigens using cytometry by time of flights (CyTOF) |
| Pain threshold | Measurement is taken at a single time point right after enrollment | Measuring pressure tolerancy in Newton by means of an algometer at the iliotibial tract, phalanx distalis III, trapezius muscle in triplicates |
| Orthostasic Tolerance | Measurement is taken at a single time point right after enrollment | blood pressure and heart rate are measured during the 10-minute standing test to determine orthostasic tolerance |
| Grip strength | Measurement is taken at a single time point right after enrollment | Hand dynamometer test to assess grip strength in Newton |
| Smell test | Measurement is taken at a single time point right after enrollment | Recognition of different substances |
Contacts
Primary ContactProf. Dr. med. Uta Behrends
Outcome results
None listed